Multiple biopsy device

ABSTRACT

A biopsy device includes a first jaw and a second jaw pivotally connected to the first jaw through a pivot. The second jaw has a lever arm extending rearward from the pivot when the second jaw is closed. A wire having an end is connected to the lever arm of the second jaw. A suction tube is disposed between the first and second jaw.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to U.S. Provisional Application No.61/317,036 filed Mar. 24, 2010, the entirety of which is incorporatedherein.

FIELD OF INVENTION

The present application relates to a biopsy device. More particularly,the present application relates to an endoscopic biopsy deviceconfigured to take multiple tissue samples.

BACKGROUND

Endoscopic biopsy procedures may be performed with an endoscope and anendoscopic biopsy forceps device. The endoscope is a long flexible tubewith various optical features allowing for visualization and having anarrow lumen through which the biopsy forceps device is inserted. Knownbiopsy forceps devices for endoscope use include a long flexible cannulahaving a pair of opposed jaws at the distal end and manual actuationmeans at the proximal end. Manipulation of the actuation means opens andcloses the jaws.

During a biopsy tissue sampling operation, an operator guides theendoscope to the biopsy site while viewing a video image of the site.When the device is inserted into the endoscope with the opposed jawsextending from the narrow lumen of the scope, the operator can positionthe jaws around a tissue to be sampled and manipulate the actuationmeans so that the jaws close around the tissue. The normal closingaction of the jaws may sever a tissue sample and in some cases, theoperator may need to apply an additional pulling or closing force tosever a tissue sample. In one known single biopsy embodiment, theoperator must first deliver the jaws to the tissue site via theendoscope lumen, sever the tissue sample with the jaws, withdraw thebiopsy forceps device from the endoscope, and open the jaws to collectthe single biopsy tissue sample from within.

With the single biopsy embodiment, the device must be repeatedlyinserted, actuated, and withdrawn to acquire multiple tissue samples ina one-at-a-time manner. In another known embodiment of a multiple biopsydevice, suction is used to retrieve the tissue sample while the distalend of the biopsy forceps device remains in the patient. In yet anotherembodiment, a suction passage is added to the biopsy device so that eachbiopsy sample can be withdrawn out of from the patient and retrievedfrom outside of the patient without withdrawing the instrument.

SUMMARY

A biopsy device includes a first jaw and a second jaw pivotallyconnected to the first jaw through a pivot. The second jaw has a leverarm extending rearward from the pivot when the second jaw is closed. Awire having an end is connected to the lever arm of the second jaw. Asuction tube is disposed between the first and second jaw.

BRIEF DESCRIPTION OF THE DRAWINGS

In the accompanying drawings, structures are illustrated that, togetherwith the detailed description provided below, describe exemplaryembodiments of the claimed invention.

In the drawings and description that follows, like elements areidentified with the same reference numerals. The drawings are not toscale, and the proportion of certain elements may be exaggerated for thepurpose of illustration.

FIG. 1 is a perspective view of one embodiment of an endoscopic biopsyassembly;

FIG. 2A is a first perspective view of a distal end of one embodiment ofa biopsy forceps device of the endoscopic biopsy assembly, showing jawsin an open position;

FIG. 2B is a second perspective view of the distal end of the biopsyforceps device, showing jaws in a closed position;

FIG. 2C is a top plan view of one embodiment of a movable jaw of thebiopsy forceps device;

FIG. 2D is a top plan view of one embodiment of a stationary jaw of thebiopsy forceps device;

FIG. 3 is a cross-section of the distal end of the biopsy forcepsdevice;

FIG. 4 is a partial perspective view of one embodiment of a catheter andwire assembly of the endoscopic biopsy assembly;

FIG. 5 is a perspective view of an alternative embodiment of a catheterassembly of the endoscopic biopsy assembly;

FIG. 6 is a front view of another alternative embodiment of a catheterof the endoscopic biopsy assembly;

FIG. 7 is a side view of one embodiment of a connector and actuationhandle of the endoscopic biopsy assembly;

FIG. 8 is a perspective view of assembled connecting componentsconfigured to be housed in the connector;

FIG. 9 is a cross-section of the connector of the endoscopic biopsyassembly;

FIG. 10 is a cross-section of an alternative embodiment of a connectorof an endoscopic biopsy assembly;

FIG. 11 is a perspective view of one embodiment of a housing in thealternative embodiment of the connector;

FIG. 12 is a perspective view of an alternative embodiment of anendoscopic biopsy assembly;

FIGS. 13A-C are cross-sections of a biopsy forceps device in thealternative embodiment of the endoscopic biopsy assembly, at variousstages of taking a biopsy sample;

FIG. 14 is a cross-section of another alternative embodiment of a biopsyforceps device, taking a biopsy sample; and

FIG. 15 is a cross-section of another alternative embodiment of a biopsyforceps device, taking a biopsy sample.

DETAILED DESCRIPTION

FIG. 1 is a perspective view of one embodiment of an endoscopic biopsyassembly 100. The endoscopic biopsy assembly 100 is for use with anendoscope (not shown) and includes a biopsy forceps device 200 disposedtherein. The endoscope may be any known endoscope. In one knownembodiment, the endoscope is an Olympus 160-series endoscope.

A catheter 205 is operatively connected to the biopsy forceps device200, and passes through the endoscope and a connector 300, to a samplecollection chamber 105. In the illustrated embodiment, the collectionchamber includes a tube 110, having an aperture for receiving a tray 115with a handle. The tray 115 may be slidably removed from the aperture.In one embodiment, the tray 115 may be held in place by a lockingmechanism (not shown). Such a locking mechanism may include a pivotingor flexible member and a projection that is received in an aperture ofthe handle of the tray 115.

In the illustrated embodiment, the tray 115 has a single samplereceiving surface. In an alternative embodiment (not shown), the trayincludes one or more dividers that define a plurality of samplereceiving surfaces. The dividers may be walls that extend upwards from abottom surface of the tray, or the dividers may be indentations formedin the bottom surface of the tray. Such a tray may be moved within thesample collection chamber 105, such as by sliding, pivoting, orrotating, to receive samples on the different sample receiving surfaces.

Alternatively, the sample collection chamber 105 may be any existingcollection chamber. In one known embodiment (not shown), the samplecollection chamber 105 is a polypectomy trap adapter commerciallyavailable under the name ETRAP polyp trap and sold by U.S. Endoscopy.The sample collection chamber 105 may include multiple componentsconstructed of polymeric materials, such as thermoplastic elastomers orclear rigid plastic.

An actuation handle 400 is also operatively connected to the biopsyforceps device 200 through connector 300. As will be described infurther detail below, the actuation handle 400 includes a sliding memberand a shaft. The sliding member may be manually translated along theshaft, which causes the biopsy forceps device 200 to open and close. Theactuation handle 400 may be constructed of metal or a polymericmaterial, such as acrylonitrile butadiene styrene (“ABS”) plastic.

In the illustrated embodiment, the sample collection chamber 105,connector 300, and actuation handle 400 are spaced from each other. Inalternative embodiments (not shown) one or more of the sample collectionchamber 105, connector 300, and actuation handle 400 may be directlyattached to each other. Such attachments may be permanent attachments orreleasable attachments. For example, in one embodiment (not shown), thesample collection chamber 105 is fixedly or releasably attached to theactuation handle 400. In another embodiment (not shown), the samplecollection chamber 105 is releasably attached to the connector 300. Inyet another embodiment, the connector 300 is releasably attached to theactuation handle 400. Releasable attachments may be formed by clips,VELCRO, snaps, threaded connectors, or other known releasableconnectors. Fixed attachments may be formed by adhesive, bolts, rivets,welds, and other known fixed connectors. A fixed attachment may also beformed by molding two or more components as a single component.

In the illustrated embodiment, a suction device (not shown) is connectedto a suction end S of a tube T, and the tube T is operatively connectedto the sample collection chamber 105. A valve V is disposed along tubeT. When the suction device is turned on and the valve V is open, suctionis applied through the tube T, and through the sample collection chamber105 and catheter 205 to the distal end of the biopsy forceps device 200.The tray 115 in the sample collection chamber 105 includes a pluralityof apertures, so as not to interrupt suction along the tube T to thebiopsy forceps device 200. When the suction device is turned on and thevalve V is closed, suction is only applied through a portion of the tubeT.

In the illustrated embodiment, the valve V is biased in a closedposition and is opened by a manually operated push button. In theillustrated embodiment, the valve is a trumpet valve. In an alternativeembodiment (not shown), the valve is opened by a foot pump or a clamp.In another alternative embodiment (not shown) the valve is disposed onthe sample collection chamber 105 or the catheter 205.

In operation, the operator guides the endoscope to the biopsy site whileviewing the biopsy site through various optical features allowing forvisualization. The operator positions the biopsy forceps device 200 at adesired location and actuates the actuation handle 400 to open thebiopsy forceps device 200. The operator optionally applies suctionthrough the biopsy forceps device 200 by opening the valve V. Applyingsuction at this time may cause “tenting” of the tissue, thusfacilitating the taking of a sample. The operator then actuates theactuation handle 400 to close the biopsy forceps device 200 around atissue sample. The act of closing the biopsy forceps device 200 maysever the tissue sample in some instances. In other instances, theoperator may need to apply force to withdraw the biopsy forceps device200 from the biopsy site. This additional force may help to sever thetissue sample from the site. After the sample has been severed, if thevalve V has not been previously opened, the operator opens the valve Vto apply suction. The suction evacuates the sample from the biopsyforceps device 200 and draws it through the catheter 205 to the samplecollection chamber 105. The valve V may be opened before or after theactuation handle 400 is actuated.

The endoscopic biopsy assembly 100 may be operated by one or moreoperators. For example, a first operator may guide the endoscope, asecond operator may actuate the actuation handle 400, a third operatormay open and close the valve V, and a fourth operator may retrieve thetissue sample from the sample collection chamber 105. Alternatively, asingle operator may perform each of these tasks. As another alternative,two or three operators may operate the endoscopic biopsy assembly 100,with each operator performing one or more tasks.

FIGS. 2A and 2B illustrate first and second perspective views of thebiopsy forceps device 200 connected to a catheter 205. The biopsyforceps device 200 includes a stationary jaw 210 having fenestration 215and movable jaw 220 also having fenestration 225. In alternativeembodiments (not shown), the stationary jaw 210, movable jaw 220, orboth are solid and do not include fenestrations. In another alternativeembodiment (not shown), but jaws are movable.

FIGS. 2C and 2D illustrate top plan views of the movable jaw 220 and thestationary jaw 210. Referring now to FIGS. 2A-D, each of the stationaryjaw 210 and movable jaw 220 have sharpened edges configured to cuttissue. The sharpened edges may be continuous edges or serrated edges.In the illustrated embodiment, each of the stationary jaw 210 andmovable jaw 220 have a radial curve and are cup shaped. In alternativeembodiments (not shown), the jaws may have non-radial curves, orstraight edges that form a geometric shape.

Each of the stationary jaw 210 and movable jaw 220 may be formed by ametal injection molding (“MIM”) or other processes including, but notlimited to, stamping, laser welding, sintering, and molding. The jawsmay be constructed of stainless steel, aluminum, titanium, ceramics,plastics, or other known materials.

The catheter 205 may be constructed of a polymeric material, such asTEFLON, polyethylene, polypropylene, nylon, polyetherether keytone(PEEK), and other polymeric materials. The catheter 205 may be formed byan extrusion process.

The movable jaw 220 is connected to the stationary jaw 210 by a pivot230. In the illustrated embodiment, the pivot 230 includes two poststhat extend from the movable jaw 220 and are seated in correspondingapertures of the stationary jaw 210. In an alternative embodiment (notshown), the pivot 230 includes two posts that extend from the stationaryjaw 210 and are seated in corresponding apertures of the movable jaw220. In another alternative embodiment (not shown), both the stationaryjaw 210 and the movable jaw 220 include a pair of correspondingapertures, and a pin is inserted therein to form a pivot. In each suchembodiment, the pivot may be positioned so as not to interfere with apassageway for tissue samples. In such embodiments, the pivot may bedescribed as an external pivot. Alternatively, the pivot may cross sucha passageway.

The biopsy forceps device 200 further includes suction tubing 235 havinga first end disposed within the chamber formed by stationary jaw 210 andmovable jaw 220. In the illustrated embodiment, the end of the suctiontubing 235 is positioned forward of the pivot 230, such that when themovable jaw 220 is opened, the first end of the suction tubing 235 maydirectly contact tissue. An operator may choose to apply suction priorto taking a tissue sample, such that when the valve V is open andsuction is applied through the suction tubing 235, the tissue that is indirect contact with the suction tubing 235 is raised. This may bereferred to as “tenting.” The tenting process pulls tissue between thejaws, so that when the movable jaw 220 is closed, the sharpened edges ofthe jaws may sever the tented tissue and capture a sample between thejaws. An additional backwards force may also be required to sever thetissue sample. The tissue sample is subsequently drawn down the catheterby the applied suction.

In one embodiment, the suction tubing 235 is an insert that extendspartially into the catheter. In an alternative embodiment, the suctiontubing 235 extends the length of the catheter.

The movable jaw 220 further includes a lever arm 240 having an aperture245. A wire 250 engages the lever arm 240 through the aperture 245, suchthat manipulation of the wire 250 moves the lever arm 240 about thepivot 230, causing the movable jaw 220 to open and close. The wire 250may be manipulated through the actuation handle 400.

FIG. 3 illustrates a cross-section of the biopsy forceps device 200. Ascan be seen in this view, the stationary jaw 210 further includes aledge 255 disposed opposite the cutting surface of the stationary jaw210. The ledge 255 may be created during the manufacturing process toform apertures in the stationary jaw 210 to accept the posts of themovable jaw 220. In one embodiment, a staking operation is performed tobend the ledge 255. In the illustrated embodiment, the ledge 255 forms astop, thereby defining the arc through which the movable jaw 220 maypivot. Alternatively, the ledge 255 may be dimensioned so as not tointerfere with the pivoting of the movable jaw 220.

With continued reference to FIG. 3, the aperture 245 in the lever arm240 forms a socket that engages a ball 260 at the end of the wire 250.During the manufacturing process, the outer edges of the aperture 245may be crimped or otherwise closed around the ball 260 after the wire isreceived, such that the ball will remain housed in the socket formed byaperture 245 during operation of the endoscopic biopsy assembly 100. Inone embodiment, a staking operation is performed to secure the ball 260in the socket. In an alternative embodiment (not shown), a stop isformed on the wire on the opposite side of the lever arm, such that thelever arm is sandwiched between the ball 260 and the stop.

In the illustrated embodiment, the distal end of the suction tubing 235is slightly spaced from the distal end of the jaws 210, 220. In analternative embodiment (not shown), the distal end of the suction tubing235 may be positioned adjacent the distal end of the jaws 210, 220. Inanother alternative embodiment (not shown), the distal end of thesuction tubing 235 may be further spaced from the distal end of the jaws210, 220, such that the suction tubing 235 is below the ball 260 of thewire 250. In one known embodiment, the position of the suction tubing235 may be varied before or during an operation.

FIG. 4 illustrates a partial perspective view of one embodiment of acatheter assembly 270. In this embodiment, the catheter assemblyincludes the catheter 205 and suction tubing 235. The suction tubing 235may be a separate component or it may be integral with the catheter 205.The catheter 205 may be constructed of a polymeric material such aspolytetrafluoroethylene (“PTFE”). The suction 235 tubing may also beconstructed of a polymeric material such as PTFE.

The center of the suction tubing 235 is a hollow passageway 265 throughwhich tissue samples may be drawn. The hollow passageway 265 isoperatively connected to the suction device, such that when the suctiondevice is turned on and the valve V is open, suction will be applied tothe passageway 265 and draws a severed tissue sample to the capturecontainer 105.

In the illustrated embodiment, the catheter 205 further includes a pairof lumens 275 a,b configured to receive the wire 250. Although only oneof the lumens (275 a) is used, two lumens are formed for manufacturingpurposes. Additionally, a pair of corresponding grooves 280 a,b areformed on the suction tubing 235. The grooves 280 a,b may extend theentire length of the suction tubing 235, or may only extend along aportion of the suction tubing 235. The corresponding grooves 280 a,b arealigned with the lumens 275 a,b and may restrict lateral movement of thewire 250. The inclusion of a lumen 275 for the wire 250 that is separatefrom the passageway 235 ensures that the tissue sample has a cleartravel path to the collection chamber 105. However, it should beunderstood that the lumen 275 is optional and that the wire may bedisposed along the passageway 235.

Additionally, the catheter 205 includes a pair of notches 285 a,b orother apertures configured to receive tangs 290 of the stationary jaw210 (as shown in FIG. 2D). The notches 285 a,b may extend for a portionof the catheter 205, or they may extend the entire length of thecatheter 205. During assembly of the biopsy forceps device 200, adhesivemay be placed in the notches 285 a,b such that the jaws are therebyaffixed to the catheter 205. Where adhesive is to be used, the surfacemay be scored to aid in bonding. The notches 285 a,b serve as an anchorpoint for the base of the stationary jaw 210 and prevents the jaws fromrotating relative to the catheter.

In an alternative embodiment (not shown), the notches 285 a,b arereplaced with an annular groove configured to receive a flange of thejaws. In another alternative embodiment (not shown), the catheter doesnot include notches or a groove, and the jaws are glued, welded, orotherwise affixed to the catheter.

FIG. 5 illustrates a perspective view of an alternative embodiment of acatheter assembly 500. In this embodiment, the catheter assemblyincludes the catheter 505 and suction tubing 510, wherein the suctiontubing 510 is a separate insert that is received in a hollow passageway515 of the catheter 505. The center of the suction tubing 510 is also ahollow passageway 520 for tissue samples.

In the illustrated embodiment, the catheter 505 further includes a lumen525 configured to receive a wire. The inclusion of a lumen 525 for thewire ensures that the tissue sample has a clear travel path to thecollection chamber 105.

FIG. 6 illustrates a front view of an alternative embodiment of acatheter. Catheter 605 may be employed in catheter assembly 270 or 500,or other variations. The catheter 605 includes a hollow passageway 610.The catheter 605 does not include any lumens for a wire. Instead, thewire may be disposed along the passageway 610.

FIG. 7 illustrates a side view of one embodiment of a connector 300 andactuation handle 400 of the endoscopic biopsy assembly 100. Theconnector 300 is a substantially “y-shaped” component, having a majorchamber 305 and a minor chamber 310. The catheter 205 passes through themajor chamber 305 to the sample collection chamber 105. A cable 315leads from the minor chamber 310 to the actuation handle 400.

The actuation handle 400 includes a shaft 405 having a distal end 410and a proximal end 415. In the illustrated embodiment, the proximal end415 has a first ring 420 attached thereto. The first ring 420 isconfigured to receive an operator's thumb or finger. However, it shouldbe understood that the ring may be omitted or replaced with atransversely oriented member.

A sliding member 425 is slidably mounted to the shaft 405. In theillustrated embodiment, the sliding member 425 includes a second ring430 and a third ring 435, each configured to receive an operator'sfinger or thumb. Alternatively, the sliding member 425 may be a spool,or include a transversely oriented member in lieu of rings.

A proximal end of the wire 250 is fixedly attached to the sliding member425. When the sliding member is translated towards the proximal end 415of the shaft 405, the wire 250 is refracted. This retraction causes theball 260 at the opposite end of the wire 250 to pull the lever arm 240of the movable jaw 220, which causes the movable jaw 220 to pivottowards the closed position. Likewise, when the sliding member istranslated towards the distal end 410 of the shaft 405, the wire 250 ispushed forward. This movement causes the ball 260 at the opposite end ofthe wire 250 to push the lever arm 240 of the movable jaw 220, whichcauses the movable jaw 220 to pivot towards the open position.

FIG. 8 illustrates a perspective view of assembled connecting componentsdisposed within the connector 300. In this embodiment, the catheter 205connected to the biopsy forceps device 200 includes a first catheter 205a and a second catheter 205 b. End portions of each of the first andsecond catheters 205 a,b are disposed in an aligning member 320. Thealigning member 320 is a hollow rod having an elongated cavity toreceive the first and second catheters 205 a,b. The aligning member 320further includes a side opening 325. In the illustrated embodiment, theside opening 325 is formed by a chamfer extending downwards to thecavity and outwards to an end of the aligning member 320. In analternative embodiment (not shown), the side opening may extend theentire length of the aligning member 320. In another alternativeembodiment (not shown), the side opening may be a hole or slot that doesnot extend to an end of the aligning member 320.

The connecting components may be assembled in the following manner. Afirst end of the first catheter 205 a is inserted into a first end ofthe aligning member 320. The first catheter 205 a may be affixed in itsposition with adhesive, or by a press fit. The first end of the firstcatheter 205 a includes a notch 330 that provides an exit for the cable315. The first catheter 205 a is positioned such that the notch 330 andthe cable 315 are accessible through the side opening 325 of thealigning member 320. In the illustrated embodiment, a flap of thecatheter remains in place over the notch 330. This flap may shield thewire from adhesive that is applied during assembly.

A first end of the second catheter 205 b is then inserted into a secondend of the aligning member 320, such that it abuts the first end of thefirst catheter 205 a. The second catheter 205 b may be affixed in itsposition with an adhesive or by a press fit.

FIG. 9 illustrates a cross-section of the connector 300. As explainedabove, the first and second catheters 205 a,b pass through the majorchamber 305 of the connector 300. A first outer tube 335 surrounds thecatheter 205 at a front end of the major chamber 305, forward from thealigning member 320. A second outer tube 340 surrounds the catheter 205at a rear end of the major chamber 305. The first and second outer tubes335, 340 may prevent crimping or strains on the catheter 205 near theconnector 300. In an alternative embodiment (not shown), a single outertube may extend through the entire connector 300. In another alternativeembodiment (not shown), no outer tubes are included.

As further explained above, a cable 315 extends from the minor chamber310. A portion of the cable 315 is shown in cutaway for illustrativepurposes. The cable 315 may be a sheath spring having tubing 345disposed therein. In one embodiment, the tubing 345 is PEEK tubing. Thewire 250 is disposed within the cable 315. The wire 250 extends from thesliding member 425 of the actuation handle 400, through the cable 315and the minor chamber 310, and joins the catheter 205 inside the majorchamber 305 of the connector 300. The wire 250 either extends through alumen or the hollow passageway in the catheter 205. The cable 315 mayact as a dampener that prevents the sliding member 425 of the actuationhandle 400 from being translated too quickly or violently.

In the illustrated embodiment, the minor chamber 310 extends from themajor chamber 305 at an angle of approximately 15°. In alternativeembodiment, the minor chamber 310 may extend from the major chamber atan angle between 5° and 60°. A smaller angle may be preferable toprevent crimping of the wire 250.

In the illustrated embodiment, the major chamber 305 also includes asterilization hole 350. The sterilization hole 350 is configured toreceive sterilizing material, such as ethylene oxide, as may be neededor desired.

FIG. 10 illustrates a partial cross-section of an alternative embodimentof a connector 700 of an endoscopic biopsy assembly. The connector 700is substantially the same as the connector 300, except for thedifferences described herein. Like reference numbers indicate likecomponents. The connector 700 includes a major chamber 705 having anenlarged cavity portion 710 sized to accept a housing 715. The housing715 surrounds portions of the aligning member 320, the first catheter205 a, and the second catheter 205 b.

FIG. 11 illustrates a perspective view of the housing 715. The housing715 has a through hole 720 and tapered ends 725, 730, and may form aseal around the enclosed components. As best shown in FIG. 10, a distalend of the housing 715 surrounds a cylindrical distal end of aligningmember 320 to create a seal therewith. If desired, small gaps orclearances can be filled with adhesive, grease, sealing compounds andthe like to create an air-tight seal. A proximal end of aligning member320 includes the side opening 325 (see FIG. 8). The side opening 325creates a gap between housing 715 and second catheter 205 b for thepassage of an “S” portion of cable 315. While not shown, the gap may befilled around the cable 315 with a seal 316 such as an elastomeric sealor adhesive. The cable 315 may also be lubricated to prevent stickingwith the seal 316. In an alternative embodiment (not shown), the ends ofthe housing are straight.

The housing 715 may be constructed of a polymeric material such as butnot limited to ABS or any one of a number of metals. In one embodiment,the housing 715 is constructed at least partially of rubber to aid insealing the enclosed components. In an alternative embodiment (notshown), o-rings or other seals may be disposed within the housing.

FIG. 12 illustrates a perspective view of an alternative embodiment ofan endoscopic biopsy assembly 800. The endoscopic biopsy assembly 800 issubstantially the same as the endoscopic biopsy assembly 100 shown inFIG. 1, except for the differences described herein. Like referencenumbers indicate like components.

The endoscopic biopsy assembly 800 includes a radio frequency (RF)generator 805 connected to the actuation handle 400. In this embodiment,at least one of the jaws 210, 220 is formed from an electricallyconductive material, such as stainless steel, and the RF generator 805is in electrical communication with the electrically conductive jaw. Inone particular embodiment, both jaws 210, 220 are formed from anelectrically conductive material. In FIG. 12, handle 400 includes an RFconnector socket positioned distal to a dual ring portion of the handle.The RF connector socket is electrically connected to the jaws 210, 220via at least wire 250 for the delivery of RF energy to the jaws.

In this embodiment, the RF generator 805 is in electrical communicationwith at least one of the jaws 210, 220 through the wire 250. The RFgenerator 805 is also in electrical communication with an actuator 810that is used by the surgeon to deliver RF energy when required. When theactuator is activated, RF energy is provided to at least one of the jaws210, 220 that can cauterize or cut the tissue. The RF generator 805 mayinclude a wave form selection switch (not shown) that allows an operatorto select between a cauterizing waveform and a cutting waveform. In theillustrated embodiment, the actuator 810 is a foot pedal. However, itshould be understood that any actuator may be employed, such as buttons,dials, and switches.

In the illustrated embodiment, the RF generator 805 has a first pole 815(i.e., a positive pole) and a second pole 820 (i.e., a negative pole ora ground pole). In the illustrated embodiment, only the first pole 815is in electrical communication with at least one of the jaws 210, 220,making the biopsy forceps device 200 a monopolar device. The second pole820 is connected to a ground pad 825. The pad 825 is placed under thepatient to form an electrical ground between the patient and the RFgenerator 805. In alternative embodiments (not shown), the second pole820 may be in electrical communication with any conductive object thatcan contact or be placed proximal to a patient.

In an alternative embodiment (not shown), both positive and negativepoles are in electrical communication with the jaws 210, 220, making thebiopsy forceps device 200 a bipolar device. In such an embodiment, oneof the first and second poles 815, 820 is in electrical communicationwith jaw 210 through a first wire, and the opposite pole is inelectrical communication with jaw 220 through a second wire. Such anembodiment will electrically isolate each jaw 210, 220 and the first andsecond wires from electrical contact with the other to prevent shorting.To provide an electrical path to tissue, each electrically isolated jaw210, 220 has an electrically conductive area exposed in the tissueclamping area, such as the horseshoe shaped sharpened edges that areshown contacted together when the jaws are fully closed. With thisembodiment, when the empty jaws are fully closed, the electrical contactareas will short together, and prevent the generator from activating.When tissue is between the clamped jaws, the tissue provides electricalresistance in the flow path between the exposed sharpened edges, and thegenerator will actuate and coagulate the clamped tissue.

For the bipolar embodiment, each jaw 210, 220 may include additionalinsulation or electrically non-conductive materials or coatings. Forexample, portions of the jaws may be constructed of ceramic or apolymeric material. In one exemplary embodiment, but not limitedthereto, each jaw can be completely ceramic coated with an insulatinglayer, and portions of the insulating layer can be removed (by grinding,masking or the like) at the wire contact area and at the horseshoeshaped tissue biting area. In this embodiment, electrical energy of onepole is conducted along the insulated wire, into the jaw 210 or jaw 220at the wire contact area, and to tissue through the exposed horseshoeshaped tissue biting area. Such an embodiment may also deliver morefocused energy that would not interfere with other electrical devices,such as a pacemaker in a patient.

FIGS. 13A-C illustrate cross-sections of the biopsy forceps device 200of the alternative embodiment of the endoscopic biopsy assembly 800, atvarious stages of taking a biopsy sample.

In FIG. 13A, the biopsy forceps device 200 has been positioned at adesired location, the jaws 210, 220 have been opened, and a potentialtissue sample, such as a polyp, is shown positioned partially inside thejaws 210, 220. Once the tissue is in the jaws, suction is appliedthrough suction tubing 235, which causes “tenting” or drawing of thetissue at least partially into the suction tubing 235 as shown. Ifdesired, a larger bite of tissue can be taken by pushing the jaws 210,220 farther into the tissue wall.

In FIG. 13B, the operator has actuated the actuation handle 400 to closethe jaws 210, 220 of biopsy forceps device 200 around a tissue sample asit is being tented and drawn into the suction tubing 235. The act ofclosing the biopsy forceps device 200 pinches the “tented” tissue at thebase of the polyp and in this view has fully severed the tissue samplejust before it is drawn farther into the suction tubing 235 by theapplied suction. In other instances, the tissue sample may not besevered entirely between the jaws 210, 220 and the operator may applyforce (i.e., by pulling or shaking) to fully sever the tissue samplefrom the site. In still other instances, the operator may activate theRF generator to apply RF energy at the jaws to cut the tissue samplefrom the site. The operator may select a cutting wave form prior toactivating the RF generator.

In FIG. 13C, the closing of the jaws has failed to sever the tissuesample and, the operator is activating the RF generator to applymonopolar RF energy at the jaws to cauterize the tissue around the site.The operator may select a cauterizing wave form, such as a square wave,prior to activating the RF generator. Cauterizing the site in thismanner may staunch bleeding caused by the severing, and may also killcancer cells at the site. Because the un-severed sample is inside of thejaws, it is prevented from contacting the negatively charged patient andis not burned when the RF energy is applied. The tissue cannot becoagulated because it is exposed to only positive RF energy whichtravels along the external skin of the jaws and to the negativelycharged patient. After applying RF energy, the operator elects to pulland shake the tissue sample free so that it can be sucked into thesuction tubing 235

FIG. 14 illustrates a cross-section of the biopsy forceps device 200 asit extends from a distal end of an endoscope 900, while taking a biopsysample. The biopsy forceps device 200 is the same as biopsy forcepsdevice 200 shown in FIGS. 1-3, except for the placement within theendoscope 900. Like reference numbers indicate like components.

The endoscope 900 has a tube 905 that includes a first lumen 915 that isconfigured to receive the biopsy forceps device 200. Catheter 205 isshown extending along the first lumen 915 of endoscope 900 with the jaws210, 220 extending from the endoscope 910. Endoscope 900 furthercomprises a second lumen 910 in communication with a fluid source forproviding irrigation to tissue and to the jaws 210, 220. In theillustrated embodiment, a plurality of tissue samples have accumulatedwithin the suction tubing 235 and the operator may irrigate the surgicalsite by providing fluid through the second lumen 915 of the endoscope900. The fluid may be used to clean the biopsy site or used to wash theaccumulated tissue samples through the suction tubing 235. The fluid mayenter the biopsy forceps device 200 through the fenestrations 215, 225in the jaws 210, 220. The fluid entering the biopsy forceps device isdrawn down the suction tubing 235 when suction is applied, and may aidin washing or drawing the tissue sample down the suction tubing 235.Exemplary fluids may include water, saline, drugs or any combinationthereof.

FIG. 15 illustrates a cross-section of the biopsy forceps device 200 asit extends from the endoscope 900. In this view, suction is beingapplied to draw a stuck tissue sample down the suction tubing 235. Ifthe suction has failed to dislodge the stuck biopsy sample, the operatorcan open and close the jaws 210, 210 to dislodge the tissue sample byactivating the actuation handle 400. Repeating this opening and closingaction causes the wire 250 to move longitudinally within the suctiontubing 235 which may then rub wire 250 against the tissue sample and aidin drawing it through the suction tubing 235. This method may beeffective in dislodging a tissue sample that has become stuck, and maybe performed with or without irrigation.

It should be understood that in various embodiments, many elements ofthe endoscopic biopsy assembly 100 can be operably configured to beflexible such as, for example, but not limited to: catheter 205, suctiontubing 210, suction tubing 235, wire 250, cable 315, tubing 345, andcatheter 505. Alternately, one or more of the flexible elements can besubstantially rigid such as exemplary catheter 205 or any other elementof assembly 100.

To the extent that the term “includes” or “including” is used in thespecification or the claims, it is intended to be inclusive in a mannersimilar to the term “comprising” as that term is interpreted whenemployed as a transitional word in a claim. Furthermore, to the extentthat the term “or” is employed (e.g., A or B) it is intended to mean “Aor B or both.” When the applicants intend to indicate “only A or B butnot both” then the term “only A or B but not both” will be employed.Thus, use of the term “or” herein is the inclusive, and not theexclusive use. See, Bryan A. Garner, A Dictionary of Modern Legal Usage624 (2d. Ed. 1995). Also, to the extent that the terms “in” or “into”are used in the specification or the claims, it is intended toadditionally mean “on” or “onto.” Furthermore, to the extent the term“connect” is used in the specification or claims, it is intended to meannot only “directly connected to,” but also “indirectly connected to”such as connected through another component or components.

While the present application has been illustrated by the description ofembodiments thereof, and while the embodiments have been described inconsiderable detail, it is not the intention of the applicants torestrict or in any way limit the scope of the appended claims to suchdetail. Additional advantages and modifications will readily appear tothose skilled in the art. Therefore, the application, in its broaderaspects, is not limited to the specific details, the representativeapparatus and method, and illustrative examples shown and described.Accordingly, departures may be made from such details without departingfrom the spirit or scope of the applicant's general inventive concept.

1. A biopsy assembly comprising: a biopsy forceps device having at leastone movable jaw, wherein the movable jaw is pivotally connected to astationary jaw by a pivot; a connector; an actuation handle; a catheterextending from the biopsy forceps device and through the connector; awire extending from the actuation handle, through the connector and intothe catheter, to move the movable jaw; and a suction device operativelyconnected to the catheter.
 2. The biopsy assembly of claim 1, furthercomprising a collection chamber operatively connected to the catheter.3. The biopsy assembly of claim 2, wherein the collection chamber isconfigured to be connected to the actuation handle.
 4. The biopsyassembly of claim 1, further comprising suction tubing disposed betweenthe movable jaw and the stationary jaw, wherein an open end of thesuction tubing is positioned forward of the pivot.
 5. The biopsyassembly of claim 1, wherein the connector is a substantially y-shapedconnector having a major chamber and a minor chamber.
 6. The biopsyassembly of claim 5, wherein the catheter passes through the majorchamber of the connector.
 7. The biopsy assembly of claim 5, wherein acannula is disposed between the minor chamber of the connector and theactuation handle.
 8. The biopsy assembly of claim 7, wherein the wire isdisposed within the cannula and passes through the minor chamber of theconnector.
 9. The biopsy assembly of claim 7, wherein the cannulacomprises a spring.
 10. The biopsy assembly of claim 1, wherein thecatheter has at least one lumen, and the wire is at least partiallydisposed within the at least one lumen.
 11. The biopsy assembly of claim1, wherein the at least one of the jaws is operably configured todeliver radio frequency energy to tissue.
 12. A biopsy device configuredto be used with an endoscope, the biopsy device comprising: a biopsyforceps device having a first jaw and a second jaw; a pivot connectingthe first jaw to the second jaw; a catheter extending from the biopsyforceps device; and a suction tube disposed between the first jaw andthe second jaw, the suction tube having an end positioned forward and atleast partially between the pivot.
 13. The biopsy device of claim 12,wherein the first jaw includes a lever arm rearward of the pivot whenthe first jaw is closed.
 14. The biopsy device of claim 13, furthercomprising a wire having a first end connected to the lever arm of thefirst jaw and a second end connected to an actuation mechanism.
 15. Thebiopsy device of claim 14, wherein the wire of the biopsy device isoperably configured to deliver RF energy to at least one jaw.
 16. Thebiopsy device of claim 12, wherein at least one of the first jaw andsecond jaw is fenestrated.
 17. A biopsy device comprising: a first jaw;a second jaw pivotally connected to the first jaw through a pivot, thesecond jaw having a lever arm extending rearward from the pivot when thesecond jaw is closed; a wire having an end connected to the lever arm ofthe second jaw; and a suction tube disposed between the first and secondjaw.
 18. The biopsy device of claim 17, further comprising a catheterextending from the first jaw with the suction tube and wire disposedwithin.
 19. The biopsy device of claim 18, wherein the first jaw has atleast one tang extending from a rear end, and a distal portion of thecatheter includes at least one aperture configured to receive the atleast one tang.
 20. The biopsy device of claim 18, further comprising atube having a plurality of lumens including at least a first lumen thatreceives the catheter and a second lumen in communication with a fluidsource.